Riverpoint Medical recalls 18G Brachy Grid (RPG-18) due to lack of EU approval. This device is used in brachytherapy procedures but is not approved for sale in the European Union.
Product is labeled with "CE", but is not yet approved in the European Union.
Riverpoint Medical is recalling its 18G Brach: Grid B&K style (RPG-18) because it is labeled with 'CE' but not approved in the European Union. This means the product is not legally allowed for sale in the EU, though it may still be used in other regions.
The product is labeled with 'CE' (indicating it meets European safety standards) but has not been approved for sale in the European Union. This means it may not meet EU regulatory requirements, potentially leading to safety issues if used in EU facilities.
Patients and medical professionals who use this brachytherapy grid in procedures within the European Union are affected. Those outside the EU may not be at risk as the product is not intended for EU markets.
Check for the model number RPG-18 on the product. The lot numbers 18061816 and 18101521 are associated with this recall. The product is used in brachytherapy procedures to assist with precise needle placement.
Look for the model number RPG-18 and lot numbers 18061816 or 18101521 on the device.
The recall states the product is labeled with 'CE' but not approved in the EU, so it may not meet EU safety standards. However, it is intended for use outside the EU.
Riverpoint Medical recalls the 18G Brachy Grid because it is labeled with 'CE' but has not been approved for sale in the European Union.
The recall does not specify a remedy, so no action is required beyond checking if you have the model and lot numbers.
We’ve drafted a message you can send Riverpoint Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0777-2019 — Riverpoint Medical Riverpoint Medical Hello, I own a Riverpoint Medical that is covered by recall Z-0777-2019 from Riverpoint Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
